Curity 6939Recalls & reported problems
Cardinal Health, Inc. · Gauze Sponges,12 Ply · Class 1
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10884521059320), received between Dec 12, 2016 and Jun 11, 2024 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Material Frayed” (3 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Material Frayed3
Patient problems
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionJun 11, 2024
FOREIGN MATERIAL INSIDE STERILE PACKAGE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19509869 ↗MalfunctionMar 17, 2020Material Frayed; Material Frayed
THE CUSTOMER REPORTED THAT THE GAUZE WAS FRAYING. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT THEY USE THE GAUZE TO WIPE MULTIPLE WIRES/CATHETERS THAT ARE ENTERING THE PATIENT THROUGH A SHEATH DURING A CEREBRAL ANGIOGRAM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9843317 ↗MalfunctionMar 17, 2020Material Frayed; Material Frayed
THE CUSTOMER REPORTED THAT THE GAUZE WAS FRAYING. ADDITIONAL INFORMATION PROVIDED BY THE CUSTOMER STATED THAT THEY USE THE GAUZE TO WIPE MULTIPLE WIRES/CATHETERS THAT ARE ENTERING THE PATIENT THROUGH A SHEATH DURING A CEREBRAL ANGIOGRAM.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 9843296 ↗MalfunctionDec 12, 2016Material Frayed
THE CUSTOMER REPORTS THERE IS A LOT OF LINT ON THE GAUZE AND IN THE PACKAGE. THEY CAN NOT HAVE LINT IN THEIR OR AREAS. THE PRODUCT WAS NOT UNFOLDED OR UNROLLED. THE CUSTOMER NEVER USED THE PRODUCT BECAUSE WHEN THEY OPENED IT AND EXAMINED IT THERE WAS A LOT OF LINT.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 6165893 ↗
Other FIBER, MEDICAL, ABSORBENT devices
- MEDLINE MDT2168204Medline Industries, Inc. · FIBER, MEDICAL, ABSORBENT18 reports
- MEDLINE MDT2168284Medline Industries, Inc. · FIBER, MEDICAL, ABSORBENT14 reports
- MEDLINE MDT2168286Medline Industries, Inc. · FIBER, MEDICAL, ABSORBENT11 reports
- MEDLINE MDT2168304Medline Industries, Inc. · FIBER, MEDICAL, ABSORBENT6 reports
- MEDLINE MDT2168210Medline Industries, Inc. · FIBER, MEDICAL, ABSORBENT5 reports
- CARDINAL HEALTH 28700-006Cardinal Health 200, LLC · FIBER, MEDICAL, ABSORBENT4 reports
- MEDLINE MDT2168202Medline Industries, Inc. · FIBER, MEDICAL, ABSORBENT4 reports
- MEDLINE MDT2168206Medline Industries, Inc. · FIBER, MEDICAL, ABSORBENT3 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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